Viamed Surgical Blades - Sterilance Medical (Suzhou) Inc.

Duns Number:554434897

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More Product Details

Catalog Number

-

Brand Name

Viamed Surgical Blades

Version/Model Number

12#

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GES

Product Code Name

Blade, Scalpel

Device Record Status

Public Device Record Key

e01b012f-acb5-460b-9404-1820b31248ce

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Additional Identifiers

Package DI Number

36945630112400

Quantity per Package

5000

Contains DI Package

16945630112406

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"STERILANCE MEDICAL (SUZHOU) INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 10